Application of Performance Test Method in Korea for LED Optical Medical Device Samples

Abstract

This study obtained key performance items related to phototherapy and the standards of light-emitting diode (LED) phototherapy devices through the published literature to secure LED phototherapy device safety in South Korea. Based on these items and IEC 62471-1 for the photobiological safety of lamps and lamp systems, a performance test method and wavelength parameters, which are the main performance indicators of the LED phototherapy device, were derived. We conducted a performance test derived from this study using samples with the same performance as the sample that is being developed. The samples comprised a laser and IR LED, red LED, and blue LED. All samples were within ±5%, of the standard threshold. The 455 nm blue LED and 625 nm red LED were close to the set value with a difference of 1 to 2 nm; their wavelengths’ accuracy was within ±0.32%, ±0%, and ±0.219%, depending on the samples’ wavelengths, which was the same or similar to the error range of ±0%. As for laser and IR LED, the difference from the set value was as large as 2 to 7 nm, and their error ranges were close to ±1%, as shown by ±0.615%, ±0.828%, or ±0.591%, which were larger than the values for red and blue LEDs.

Keywords

• LED phototherapy device
• safety
• medical device